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Simvastatin Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 6536 

Hepatitis C Virus Test Positive, Neutropenia, Eosinophil Count Decreased, Salivary Hypersecretion, Thrombocytopenia, Mental Impairment, Psychotic Disorder (8472112-7)
on Jun 13, 2012 Male from UNITED KINGDOM , 48 years of age, was diagnosed with
  • blood cholesterol increased
  • schizophrenia
and was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: hepatitis c virus test positive, neutropenia, eosinophil count decreased, salivary hypersecretion, thrombocytopenia, mental impairment, psychotic disorder. Simvastatin dosage: 40 Mg, Daily.
Associated medications used:
  • Olanzapine (10 Mg, Daily)
  • Risperidone (1 Mg, Bid)
  • Citalopram Hydrobromide (10 Mg, Daily)
  • Pirenzepine (50 Mg, Tid)
  • Valproic Acid (250 Mg, Tid)
  • Clozaril (Unk)
  • Clozaril (100 Mg Morning And 250 Mg Ncte)
Patient was hospitalized.

Cerebrovascular Accident (8471978-4)
Patient was taking Simvastatin. Patient felt the following Simvastatin side effects: cerebrovascular accident on Jun 25, 2012 from ROMANIA Additional patient health information: Male , weighting 154.3 lb, . Simvastatin dosage: N/A.
Multiple prescriptions taken:
  • Diosminum
  • Pentoxifilin
  • Amlodipine
  • Zemplar
  • Aspenter
  • Metoprolol Tartrate
  • Indapemid
  • Isosorbidi Dinitras


Hypoaesthesia, Transient Ischaemic Attack, Pain, Cerebrovascular Accident, Cerebral Infarction, Injury, Cerebellar Infarction, Gliosis, Cerebral Ischaemia (8471865-1)
Adverse event was reported on Jun 19, 2012 by a Female taking Simvastatin (Dosage: Unk) . Location: UNITED STATES , 25 years of age, weighting 180.0 lb, After Simvastatin was administered, patient encountered several Simvastatin side effects: hypoaesthesia, transient ischaemic attack, pain, cerebrovascular accident, cerebral infarction, injury, cerebellar infarction, gliosis, cerebral ischaemia. Patient was hospitalized.

Condition Aggravated, Panic Attack, Cerebral Infarction, Anxiety (8471018-7)
on Jun 08, 2012 Female from UNITED KINGDOM , 83 years of age, was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: condition aggravated, panic attack, cerebral infarction, anxiety. Simvastatin dosage: 40 Mg;qd; Po.
Associated medications used:
  • Citalopram Hydrobromide
  • Clopidegrel (175 Mg;qd; Po)



Amnesia, Fatigue (8470799-6)
on Jun 13, 2012 Female from , 55 years of age, weighting 201.7 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Simvastatin. Patient felt the following Simvastatin side effects: amnesia, fatigue. Simvastatin dosage: (20 Mg).

White Blood Cell Count Decreased, Psychotic Disorder, Hepatitis C Virus Test Positive, Eosinophil Count Decreased, Mental Impairment, Salivary Hypersecretion, Self-injurious Ideation, Thrombocytopenia, Neutropenia (8470795-9)
Patient was taking Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: white blood cell count decreased, psychotic disorder, hepatitis c virus test positive, eosinophil count decreased, mental impairment, salivary hypersecretion, self-injurious ideation, thrombocytopenia, neutropenia on Jun 13, 2012 from Additional patient health information: Male , 48 years of age, . Simvastatin dosage: N/A.
Multiple concurrent drugs taken:
  • Olanzapine
  • Pirenzepine (pirenzepine) (150 Mg (50 Mg, 3 In 1 D), Oral)
  • Clozaril ((350 Mg), Oral)
  • Citalopram Hydrobromide
  • Risperidone (2 Mg (1 Mg, 2 In 1 D), Oral)
  • Valproic Acid
Patient was hospitalized.

Musculoskeletal Disorder, Dyspnoea, Cerebrovascular Accident, Vomiting, Abdominal Pain, Diarrhoea (8469431-7)
Adverse event was reported on Jun 21, 2012 by a Male taking Simvastatin (Dosage: 10 Mg 1/2 Tablet Nightly Mouth) . Location: UNITED STATES , weighting 170.0 lb, Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: musculoskeletal disorder, dyspnoea, cerebrovascular accident, vomiting, abdominal pain, diarrhoea. Patient was hospitalized.

Lividity, Unresponsive To Stimuli, Nephrosclerosis, Renal Adenoma, Toxicity To Various Agents, Muscle Rigidity, Completed Suicide, Cardio-respiratory Arrest, Intentional Overdose (8468905-2)
on Jun 09, 2012 Female from UNITED STATES , 62 years of age, weighting 266.8 lb, was treated with Simvastatin. Patient felt the following Simvastatin side effects: lividity, unresponsive to stimuli, nephrosclerosis, renal adenoma, toxicity to various agents, muscle rigidity, completed suicide, cardio-respiratory arrest, intentional overdose. Simvastatin dosage: N/A.
Multiple prescriptions taken:
  • Gabapentin
  • Fluoxetine
  • Clonazepam


Carotid Artery Occlusion, Blood Pressure Decreased, Hypertension (8468209-8)
on Jun 19, 2012 Male from BRAZIL , 85 years of age, weighting 211.6 lb, was diagnosed with
  • ischaemic heart disease prophylaxis
  • venous occlusion
  • sedation
and was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: carotid artery occlusion, blood pressure decreased, hypertension. Simvastatin dosage: Unk.
Multiple concurrent drugs taken:
  • Somalgin Cardio (Unk)
  • Alprazolam (1 Mg, 1x/day)
  • Atenolol (Unk)
  • Plaq (Unk)
  • Alprazolam


Bradycardia, Malaise (8466468-9)
Patient was taking Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: bradycardia, malaise on Jun 21, 2012 from UNITED KINGDOM Additional patient health information: Male , 70 years of age, weighting 200.6 lb, . Simvastatin dosage: N/A.
Associated medications used:
  • Tramadol Hcl
  • Bisoprolol Fumarate
  • Metformin Hcl


Limb Injury, Localised Infection (8464641-7)
Adverse event was reported on Jun 22, 2012 by a Female taking Simvastatin (Dosage: N/A) was diagnosed with
  • blood cholesterol increased
  • multiple sclerosis
and. Location: UNITED STATES , 58 years of age, Patient felt the following Simvastatin side effects: limb injury, localised infection.
Multiple prescriptions taken:
  • Betaseron (0.3 Mg, Qod)
Patient was hospitalized.

Pneumonia, Dizziness, Syncope (8464558-8)
on Nov 09, 2011 Male from UNITED STATES , 76 years of age, was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: pneumonia, dizziness, syncope. Simvastatin dosage: N/A.
Multiple concurrent drugs taken:
  • Tamsulosin Hcl
  • Epoetin (epoetin Alfa)
  • Allopurinol
  • Nexium
  • Omega 3 Fatty Acids (fish Oil)
  • Megace
  • Proscar
  • Renvela
Patient was hospitalized.

Jaw Disorder, Lip Swelling, Speech Disorder, Oedema Mouth, Swelling Face, Swollen Tongue (8464480-7)
on Jun 12, 2012 Male from UNITED KINGDOM , weighting 222.7 lb, was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: jaw disorder, lip swelling, speech disorder, oedema mouth, swelling face, swollen tongue. Simvastatin dosage: Unk.
Associated medications used:
  • Carvedilol (12.5 Mg, Bid)
  • Aspirin (75 Mg, Qd)
  • Ramipril (Unk)
  • Clopidogrel (75 Mg, Qd)
  • Prednisolone (Unk)
Patient was hospitalized.

Subdural Haematoma, Headache (8464312-7)
Patient was taking Simvastatin. Patient felt the following Simvastatin side effects: subdural haematoma, headache on Jun 12, 2012 from ITALY Additional patient health information: Female , 85 years of age, . Simvastatin dosage: Daily Dose 20 Mg.
Multiple prescriptions taken:
  • Aspirin (100 Mg, Qd)
  • Enalapril Maleate (Daily Dose 5 Mg)
Patient was hospitalized.

Gait Disturbance, Systemic Lupus Erythematosus Rash, Rheumatoid Arthritis (8464283-3)
Adverse event was reported on Jun 19, 2012 by a Female taking Simvastatin (Dosage: 40 Mg, Unk) . Location: UNITED STATES , 54 years of age, After Simvastatin was administered, patient encountered several Simvastatin side effects: gait disturbance, systemic lupus erythematosus rash, rheumatoid arthritis.
Multiple concurrent drugs taken:
  • Oxcarbazepine (600 Mg, Bid)
  • Enbrel (50 Mg, Unk)
  • Cloderm (Unk Unk, Bid)
  • Enbrel (Unk Unk, Q2wk)
  • Plavix (75 Mg, Unk)
  • Enbrel
  • Topiramate (100 Mg, Unk)
  • Toprol-xl (25 Mg, Unk)


Myopathy, Abdominal Discomfort, Skin Burning Sensation (8464085-8)
on Jun 12, 2012 Female from GERMANY , weighting 145.5 lb, was diagnosed with
  • low density lipoprotein increased
  • lipoprotein (a) increased
and was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: myopathy, abdominal discomfort, skin burning sensation. Simvastatin dosage: N/A.
Associated medications used:
  • Tredaptive
  • Fluvastatin Sodium


Body Height Decreased, Macular Oedema (8463636-7)
on Jun 12, 2012 Female from UNITED STATES , 84 years of age, weighting 160.1 lb, was treated with Simvastatin. Patient felt the following Simvastatin side effects: body height decreased, macular oedema. Simvastatin dosage: N/A.
Multiple prescriptions taken:
  • Lipitor
  • Multivitamin
  • Aspirin
  • Fish Oil
  • Crestor
  • Vitamin D
  • Vitamin B-12


Constipation, Diverticulitis, Abdominal Pain, Vomiting (8463632-X)
Patient was taking Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: constipation, diverticulitis, abdominal pain, vomiting on Jun 22, 2012 from UNITED KINGDOM Additional patient health information: Female , weighting 187.4 lb, . Simvastatin dosage: 20 Mg At Night.
Multiple concurrent drugs taken:
  • Levothyroxine
  • Amitriptyline Hcl (10 Mg At Night.)
  • Methotrexate
  • Doxazosin Mesylate
  • Omeprazole
  • Mobiflex
  • Mabthera (Last Dose Prior To Sae 21/dec/2010)
  • Folic Acid
Patient was hospitalized.

Shoulder Deformity, Spinal Deformity, Abdominal Distension, Movement Disorder (8463041-3)
Adverse event was reported on Jan 13, 2010 by a Female taking Simvastatin (Dosage: N/A) was diagnosed with
  • blood cholesterol abnormal
  • anxiety
  • osteoporosis
and. Location: BRAZIL , weighting 105.8 lb, Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: shoulder deformity, spinal deformity, abdominal distension, movement disorder.
Associated medications used:
  • Lexotan
  • Boniva


Rhabdomyolysis (8462765-1)
on Jun 18, 2012 Male from UNITED STATES , 61 years of age, weighting 231.6 lb, was diagnosed with
  • hyperlipidaemia
and was treated with Simvastatin. Patient felt the following Simvastatin side effects: rhabdomyolysis. Simvastatin dosage: 20 Mg Daily Po. Patient was hospitalized.

Neutropenia (8462747-X)
on Jun 20, 2012 Female from FRANCE , 86 years of age, was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: neutropenia. Simvastatin dosage: N/A.
Multiple concurrent drugs taken:
  • Keppra
  • Levothyroxine Sodium
  • Felodipine
  • Zolpidem Tartrate
  • Clonazepam
  • Amoxicillin (Brand From Teva Pharmaceutical)
Patient was hospitalized.

Renal Impairment, Renal Vessel Disorder, Blood Creatinine Increased (8462702-X)
Patient was taking Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: renal impairment, renal vessel disorder, blood creatinine increased on Jun 18, 2012 from ITALY Additional patient health information: Female , 67 years of age, . Simvastatin dosage: 20 Mg, Unk.
Associated medications used:
  • Losartan Potassium (100 Mg, Unk)
  • Atenolol
  • Gastroloc
  • Aspirin
  • Forteo


Arthralgia, Spinal Column Stenosis, Neuropathy Peripheral, Oedema, Pain (8462328-8)
Adverse event was reported on Jun 15, 2012 by a Patient taking Simvastatin (Dosage: 80 Mg, 1/2 By Mouth Everyday) . Location: UNITED STATES , weighting 239.0 lb, Patient felt the following Simvastatin side effects: arthralgia, spinal column stenosis, neuropathy peripheral, oedema, pain.
Multiple prescriptions taken:
  • Furosemide (20 Mg, As Needed)
  • Phentermine Hydrochloride (37.5 Mg, 1x/day)
  • Lyrica (75 Mg, 2x/day)
  • Humalog (100 Units/ml, 30 Units With Meal Or Per Humalog Sliding Scale)
  • Prilosec (40 Mg, 1x/day)
  • Hydrochlorothiazide (25 Mg Everyday As Needed)
  • Zofran (4 Mg, 1 By Mouth Every 6 Hours As Needed)
  • Hydrocodone Bitartrate + Acetaminophen (10-325 Mg, 1 Four Times A Day As Needed)


Bradycardia, Fall (8461633-9)
on Jun 18, 2012 Female from UNITED KINGDOM , 76 years of age, weighting 183.0 lb, was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: bradycardia, fall. Simvastatin dosage: N/A.
Multiple concurrent drugs taken:
  • Trimethoprim
  • Aspirin
  • Acetaminophen
  • Perindopril Erbumine
  • Rivastigmine
  • Citalopram Hydrobromide
  • Nitrofurantoin
  • Albuterol
Patient was hospitalized.

Hepatitis C Virus Test Positive, Neutropenia, Thrombocytopenia, Salivary Hypersecretion, Eosinophil Count Decreased, Psychotic Disorder, Mental Impairment (8461629-7)
on Jun 13, 2012 Male from UNITED KINGDOM , 48 years of age, was diagnosed with
  • blood cholesterol increased
and was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: hepatitis c virus test positive, neutropenia, thrombocytopenia, salivary hypersecretion, eosinophil count decreased, psychotic disorder, mental impairment. Simvastatin dosage: 40 Mg, Unk.
Associated medications used:
  • Clozaril (350 Mg,)
  • Risperidone (1 Mg, Bid)
  • Pirenzepine (50 Mg, Tid)
  • Valproic Acid (250 Mg, Unk)
  • Clozaril (350 Mg, Unk)
  • Citalopram Hydrobromide (10 Mg, Unk)
  • Olanzapine (10 Mg, Unk)
Patient was hospitalized.

Showing 1-25 of 6536 

Simvastatin Health Episodes

How Can Simvastatin Affect You?

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Discuss Simvastatin Side Effects

Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Simvastatin Information

Alternative SIMVASTATIN Names:SIMVASTAT

Active Ingredient: SIMVASTAT

Simvastatin Dosage, Warnings, Usage.

Side Effects reported to FDA: 6536. View Simvastatin Adverse Reports

Simvastatin safety alerts: 2011 2010 2008

Reported deaths: 418

Reported hospitalizations: 2451

Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations

Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor


 

[UPDATED 12/15/2011] FDA notified the public that it has revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction.

 

[Posted 06/08/2011]

AUDIENCE: Family Practice, Cardiology, Pharmacy

ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.

BACKGROUND: The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).

RECOMMENDATION: Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.  


Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[12/15/2011 - Drug Safety Communication - FDA
[06/08/2011 - Drug Safety Communication - FDA]
[06/08/2011 - News Release - FDA]
[06/08/2011 - Consumer Update - FDA

Previous MedWatch Alert

[03/19/2010]

Managing Your Medicines

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